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Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.

Publication ,  Journal Article
Gold, MR; Lambiase, PD; El-Chami, MF; Knops, RE; Aasbo, JD; Bongiorni, MG; Russo, AM; Deharo, J-C; Burke, MC; Dinerman, J; Barr, CS; Shaik, N ...
Published in: Circulation
January 5, 2021

BACKGROUND: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. METHODS: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points. RESULTS: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%. CONCLUSIONS: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

January 5, 2021

Volume

143

Issue

1

Start / End Page

7 / 17

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke Volume
  • Prospective Studies
  • Primary Prevention
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
  • Female
  • Defibrillators, Implantable
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Gold, M. R., Lambiase, P. D., El-Chami, M. F., Knops, R. E., Aasbo, J. D., Bongiorni, M. G., … UNTOUCHED Investigators*. (2021). Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation, 143(1), 7–17. https://doi.org/10.1161/CIRCULATIONAHA.120.048728
Gold, Michael R., Pier D. Lambiase, Mikhael F. El-Chami, Reinoud E. Knops, Johan D. Aasbo, Maria Grazia Bongiorni, Andrea M. Russo, et al. “Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.Circulation 143, no. 1 (January 5, 2021): 7–17. https://doi.org/10.1161/CIRCULATIONAHA.120.048728.
Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG, et al. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021 Jan 5;143(1):7–17.
Gold, Michael R., et al. “Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.Circulation, vol. 143, no. 1, Jan. 2021, pp. 7–17. Pubmed, doi:10.1161/CIRCULATIONAHA.120.048728.
Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG, Russo AM, Deharo J-C, Burke MC, Dinerman J, Barr CS, Shaik N, Carter N, Stoltz T, Stein KM, Brisben AJ, Boersma LVA, UNTOUCHED Investigators*. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021 Jan 5;143(1):7–17.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

January 5, 2021

Volume

143

Issue

1

Start / End Page

7 / 17

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke Volume
  • Prospective Studies
  • Primary Prevention
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
  • Female
  • Defibrillators, Implantable